UMIN-CTR Clinical Trial

Public title

Effects of Different Losartan Combination Antihypertensive Therapy in CKD Patients

Acronym

MIDLAND-CKD Study

Scientific Title

Effects of Different Losartan Combination Antihypertensive Therapy in CKD Patients

Scientific Title:Acronym

MIDLAND-CKD Study

Region

Japan

Condition

Chronic kidney disease patients complicated with hypertension

Classification by specialty

Cardiology

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Comparative effects of amlodipine with losartan versus low-dose hydrochlorothiazide with losartan on albuminuria in chronic kidney disease patients with hypertension

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Urinary albumin excretion from 0 to 3 months between 2 groups

Key secondary outcomes

A. Following parameters from 0 to 3 months between 2 groups;
1. Systolic and diastolic blood pressure
2. BNP
3. HOMA-beta and HOMA-IR
4. hs-CRP
5. eGFR
6. Urinnary sodium excretion
7. Serum K
8. HbA1c
9. Serum uric acid
10.Pulse wave velocity(PWV):optional
B. Following parameters from 0 to 6 months between 2 groups;
1. Urinary albumin excretionin
2. Serum K
3. HbA1c
4. Serum urin acid

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of losartan 50mg and hydrochlorothiazide 12.5mg by a combination drug

Interventions/Control_2

Administration of losartan 50mg and amlodipine 2.5-5mg

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1.Patients treated with losartan 50-100mg two months or more at the informed consent acquisition, and systolic blood pressure over 140, or diastolic blood pressure over 90 mmHg
2.Patients whose urinary protein in dipstic test was plus minus or greater in 2 times or more within 1 year before the informed consent acquisition
3.Outpatients
4.Sex unquestioned
5.20 and over,less than 80 years old

Key exclusion criteria

1. Patients whose serum creatinine was 2 mg/dL or greater within three months or patients whose eGFR were less than 30 mL/min/1.73 m2 before the informed consent acquisition
2. Patients whose hepatic function was over 3 times higher than normal upper limit within three months before the informed consent acquisition
3. Patients whose HbA1c was more than 8.0 within three months before the informed consent acquisition
4. Patients received hospitalizing by onset of cardiovascular disease, myocardial infarction, cerebral apoplexy, cardiac insufficiency within six months before the informed consent acquisition
5. Patients complicated angina pectoris, cardiac insufficiency with NYHA 3 or greater at the informed consent acquisition
6. Patients who is already prescribed diuretic or Ca antagonist at the informed consent acquisition
7. Patients with poor feeding
8. Patients of remarkable emaciation
9. Patients complicated with nephrotic syndrome
10. Patients judged unsuitable by physician in charge

Target sample size

120

Name of lead principal investigator

1st name
Middle name
Last name	Shoichi Maruyama

Organization

Nagoya University, Graduate School of Medicine

Division name

Department of Nephrology

Zip code

Address

65, Turumai-cho, Showa-ku, Nagoya, Aichi 466-8550

TEL

052-741-2111

Email

Name of contact person

1st name
Middle name
Last name	Yoshinari Yasuda

Organization

Nagoya University, Graduate School of Medicine

Division name

Department of Nephrology

Zip code

Address

65, Turumai-cho, Showaku, Nagoya, Aichi 466-8550

TEL

052-741-2111

Homepage URL

Email

yyasuda@med.nagoya-u.ac.jp

Institute

Nagoya University CKD Clinical Cooperation System Study Group

Institute

Department

Personal name

Organization

Research Foundation for Community Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

名古屋大学医学部附属病院（愛知県）

Date of disclosure of the study information

2010

Year

08

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2010

Year

02

Month

15

Day

Date of IRB

Anticipated trial start date

2010

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

08

Month

18

Day

Last modified on

2014

Year

08

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004458